Cleared Traditional

K790409 - LOW DEAD SPACE INSULIN SYRINGE

K790409 is the FDA 510(k) clearance for LOW DEAD SPACE INSULIN SYRINGE by Pharmaseal Div., Baxter Healthcare Corp.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K790409 · Pharmaseal Div., Baxter Healthcare Corp. · General Hospital
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Apr 1979
Decision
57d
Days
Class 2
Risk

K790409 is an FDA 510(k) clearance for the LOW DEAD SPACE INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1979 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmaseal Div., Baxter Healthcare Corp. devices

Submission Details

510(k) Number K790409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date April 24, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 312
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K790409.
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · Burron Medical Products, Inc. · Jun 1980
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · Medline Industries, Inc. · Nov 1979
PUNCTURE KIT, DISPOSALBE VEIN
K781978 · Arrow Intl., Inc. · Dec 1978
SYRINGE, INSULIN, HYPOTIP
K781154 · National Patent Development Corp. · Aug 1978
STERILE AIR SYRINGE
K780550 · National Patent Development Corp. · Apr 1978